CBER-Approved sBLA for KEDRAB® (rabies immune globulin (human))
On May 17, 2021, FDA approved an sBLA for Kamada’s KEDRAB® (rabies immune globulin (human)). The supplemental approval acknowledged the fulfillment of a postmarketing requirement (PMR) for a Required Pediatric Assessment and updated the prescribing information accordingly.
Key findings from FDA’s Clinical Review Memo:
The applicant conducted KAMRAB-004 (NCT02912845; n=30), a phase 1 trial to confirm the safety of rabies immune globulin (human) in the pediatric population and to fulfill the Required Pediatric Assessment PMR. FDA noted that KAMBRAB-004 was designed as a safety study and that it was difficult to interpret effectiveness data. The applicant also provided an RWE study to demonstrate effectiveness in the patient population.
Intent of the RWE study
The applicant provided an RWE study to support the effectiveness of rabies immune globulin (human) in pediatric patients under the age of 17.
Protocols for RWE generation
The applicant used claims data to show that 172 U.S. pediatric patients were treated with rabies immune globulin (human) between 2018 and 2020. The applicant then used Center for Disease Control and Prevention (CDC) data to show that no pediatric patient receiving post-exposure prophylaxis reported a rabies infection from 2019 to April 2021.
Additionally, the applicant used the Israeli Ministry of Health database to show that there were no active cases of rabies or death in 2,754 patients receiving post-exposure prophylaxis from an identical formulation of the product
Outcome of the RWE submission
FDA concluded that the RWE studies, specifically the U.S. data, were sufficient to support the applicant’s pediatric effectiveness claims. The Agency noted that the CDC RWE was reliable because rabies is a reportable disease in the U.S., which ensures all cases are captured. FDA included the RWE study in the product’s label.